FDA’s Ortho Panel supports the down-classification of pedicle screws

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FDA's Ortho Panel supports down-classification of pedicle screw spinal systems (MassDevice)
The FDA's Orthopedic & Rehabilitations Devices Panel agrees with the FDA's recommendations that pedicle screw spinal systems be officially down-classified to less-stringent regulatory review.
A panel of experts today recommended that FDA lower the regulatory bar for pedicle screw spinal systems, which are intended to treat degenerative disc disease and a limited type of spondylolisthesis, or shifting of vertebra in response to a vertebral stress fracture.
"What we approved for is downgrading to Clas...

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